Targeted Lens Intervention for Myopic Anisometropia in Children

Sponsor
Essilor International
Study ID
NCT07533149
Status
Not Yet Recruiting

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Conditions

  • Anisometropia
  • Myopia

Eligibility Criteria

Sex
ALL
Age
6 Years - 13 Years
Healthy Volunteers
Not accepted

Interventions

  • More myopic eye: MCL1; Less myopic eye: MCL2 — DEVICE
    Each participant wears the study eyeglasses containing both Myopia Control Lens 1 (MCL1) and Myopia Control Lens 2 (MCL2) design, with one type of lens in each eye throughout the study period. MCL1 will be worn in the more myopic eye, and MCL2 in the less myopic eye for a period of 12 months.

Study Details

The goal of this clinical trial is to learn if our research spectacles will lower the difference in prescription (spectacles degree) between the eyes in children between 6 to 13 years old with anisometropic myopia. Anisometropic myopia is when the difference in myopia prescription between the two eyes are more than 1 diopter. The main question it aims to answer is: * How the eye responds to the research spectacles over time by measuring: 1. Change in axial length: the physical length of the eye from front to back. 2. Change in cycloplegic spherical equivalent refraction: an accurate measurement of the eye's prescription taken while the focusing muscles are temporarily relaxed with eye drops. Participants will: * Wear the study spectacles * Visit Essilor R\&D Centre and an eye clinic for follow-up sessions

Key Dates

First listed
Apr 16, 2026
Start date
Apr 30, 2026
Status verified
Mar 2026
Primary completion
Jul 31, 2027
Completion
Jul 31, 2027

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: More myopic eye: MCL1; Less myopic eye: MCL2
    Each participant wears the study eyeglasses containing both Myopia Control Lens 1 (MCL1) and Myopia Control Lens 2 (MCL2) design, with one type of lens in each eye throughout the study period. MCL1 will be worn in the more myopic eye, and MCL2 in the less myopic eye for a period of 12 months.

Primary Outcome Measure

Change in axial length difference between the eyes [ Time Frame: Base line, 12 months ]

Central Contacts

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